Actively Recruiting
Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients
Led by Inkeun Park · Updated on 2026-04-13
60
Participants Needed
4
Research Sites
190 weeks
Total Duration
On this page
Sponsors
I
Inkeun Park
Lead Sponsor
S
Seoul National University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a phase 2 single-arm, open-label clinical trial designed to evaluate the efficacy and safety of tarlatamab in patients with relapsed extrapulmonary neuroendocrine carcinoma (EPNEC) who have previously received platinum-based first-line chemotherapy. Participants will receive tarlatamab on Cycle 1 Day 1 (C1D1), Day 8 (C1D8), and Day 15 (C1D15), followed by administration every two weeks thereafter. No placebo control is included in this study.
CONDITIONS
Official Title
Efficacy and Safety Evaluation of Tarlatamab in Advanced Extrapulmonary Neuroendocrine Carcinoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject has provided informed consent prior to any study activities.
- Age 19 years or older at informed consent.
- Histologically confirmed relapsed or refractory extrapulmonary neuroendocrine carcinoma, including small cell, large cell, or mixed histology.
- For prostate cancer, treatment-emergent neuroendocrine carcinoma is allowed.
- Cohort 1 includes cancers from stomach, esophagus, small intestine, colorectal, pancreas, or bile ducts.
- Cohort 2 includes cancers from prostate, bladder, ureter, urethra, or kidney.
- Disease progressed or recurred after one platinum-based chemotherapy regimen.
- Measurable disease per RECIST 1.1 within 21-day screening (or evaluable by PCWG-3 criteria for prostate cancer).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
- Minimum life expectancy of 12 weeks.
- Adequate organ function including blood counts, coagulation, kidney, liver, lung, and heart function as defined.
- Provision of tumor samples for central testing (archival or biopsy).
You will not qualify if you...
- Symptomatic central nervous system (CNS) metastases; treated brain metastases allowed if stable and asymptomatic.
- Diagnosis or evidence of leptomeningeal disease.
- Prior severe immune-related adverse events or immune-mediated CNS events.
- Active autoimmune disease requiring recent systemic treatment or immunosuppressive therapy.
- History of solid organ transplantation.
- Other malignancy within past 2 years except certain low-risk or treated cancers.
- Recent myocardial infarction, symptomatic heart failure, or arterial thrombosis within 12 months.
- Active viral infections including HIV, active hepatitis B or C.
- Use of systemic corticosteroids or immunosuppressive therapy within 7 days before first dose, except allowed low-dose corticosteroids.
- Acute or uncontrolled active systemic infection within 7 days prior to first dose.
- Evidence of interstitial lung disease or active non-infectious pneumonitis.
- Prior therapy with tarlatamab or DLL3 pathway inhibitors.
- More than 2 prior systemic therapies for EPNECs.
- Recent anti-cancer therapy within specified time frames.
- Use of medications that inhibit or induce specific enzymes or transporters affecting tarlatamab within specified time frames.
- Major surgery within 28 days prior to first dose.
- Live virus vaccination within 14 days prior to first dose.
- Participation in another investigational study within 30 days.
- Female subjects who are pregnant, breastfeeding, or unwilling to use contraception.
- Male subjects unwilling to use contraception or abstain from sperm donation.
- Known sensitivity to study products.
- Likely inability to complete study visits or comply with procedures.
- Any other clinically significant disorder or condition.
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
2
Samsung Medical Center
Seoul, South Korea
Not Yet Recruiting
3
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
4
Yonsei Severance Hospital
Seoul, South Korea
Not Yet Recruiting
Research Team
I
Inkeun Park, M.D, Ph D
CONTACT
H
Hung-Don Kim, M.D, Ph D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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